| CTRI Number |
CTRI/2024/08/072092 [Registered on: 07/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Educating children and parents to improve dental visits - a research for social benefit. |
|
Scientific Title of Study
|
Effectiveness of a school based oral health education and screening program in stimulating dental attendance of children - A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priya Mahadev Pattanshetti |
| Designation |
post graduate student |
| Affiliation |
SDM College of dental sciences and hospital, Dharwad |
| Address |
department of public health dentistry SDM College of dental sciences and hospital, Dharwad
Dharwad KARNATAKA 580009 India |
| Phone |
9740274809 |
| Fax |
|
| Email |
priyapattanshetti183@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ravi Shirahatti |
| Designation |
professor and HOD of public health dentistry |
| Affiliation |
SDM college of dental sciences and hospital |
| Address |
department of public health dentistry, SDM college of dental sciences and hospital
Dharwad KARNATAKA 580009 India |
| Phone |
7259229908 |
| Fax |
|
| Email |
shirahattiravi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravi Shirahatti |
| Designation |
professor and HOD of public health dentistry |
| Affiliation |
SDM college of dental sciences and hospital |
| Address |
department of public health dentistry, SDM college of dental sciences and hospital
Dharwad KARNATAKA 580009 India |
| Phone |
7259229908 |
| Fax |
|
| Email |
shirahattiravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry, SDM College of Dental sciences, Dharwad will oversee and provide infrastructural and other support (transport, equipment, manpower) for this trial. |
|
|
Primary Sponsor
|
| Name |
Dr Priya Mahadev Pattanshetti |
| Address |
II year postgraduate student
Department of public health Dentistry,
SDM College of dental sciences and hospital, Dharwad 580009
India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priya Mahadev Pattanshetti |
SDM college dental sciences and hospital |
room no. 10 Department of Public health Dentistry
Dharwad KARNATAKA |
9740274809
priyapattanshetti183@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Dental Sciences and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dental caries |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
improvised protocol |
improvised protocol - video based online communication or telephonic communication of parents to educate parent
|
| Comparator Agent |
traditional referral |
oral examination, oral health education and issue of referral cards to children . in the referral cards the childs oral findings and treatment required would be mentioned and will be asked to visit the nearest dentist or our institution for obtaining the treatment |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 7 to 12 years at baseline
2.Permission will be obtained for conducting the oral health education and screening at school and permission from the authority will be considered as a consent. We have applied for “wavier of consent†for individuals. However each child’s oral assent will be obtained and examination will be carried out only for the assenting children
3.Phone number of the parent / guardian is available with the child or with the school authorities.
|
|
| ExclusionCriteria |
| Details |
1.children with any mentally compromised condition such as congenital heart disease, hematological conditions, immune deficiency disease, and end stage renal disease that might modify the time taken for initiation of treatment
2.children who refuse to participate in the study
3.children scheduled for ongoing dental treatment |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
(a) the rate of dental attendance following improvised screening protocol.
(b) the rate of dental attendance following traditional school based oral screening.
(c) compare the rate of dental attendance following improvised screening protocol with traditional school based oral screening.
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.the factors associated with rate of dental attendance
(demographic factors , type of treatment needed, distance from the Dental institution, dental attendance & experience of parents )
2. the prevalence of dental caries gingival bleeding dental fluorosis ,developmental defects of tooth dental trauma amongst the school going children.
|
3 months |
1.To analyze the factors associated with rate of dental attendance
(demographic factors , type of treatment needed, distance from the Dental institution, dental attendance & experience of parents )
2.To determine the prevalence of dental caries gingival bleeding dental fluorosis ,developmental defects of tooth dental trauma amongst the school going children.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="700" Sample Size from India="700"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Karnataka , the percentage of
subjects with caries experience of dmft ranges from about 53.4 per cent in 5
year children and DMFT of about 39.1 per cent in 12 year old
children. Unfortunately, the habit of routine dental visits is not common
in our population. Majority of dental visits are undertaken only after the
child gets pain or has extensive decay. School based dental screening programs
are recommended by the WHO. A modification in the present School-based dental
screening that incorporates more effective communication between the dentist
and parent could potentially improve uptake of dental services. In our modified
method of communication to the parent after screening, we plan to improve the
involvement of parent with help of video based communication, customized health
education and telephonic reminders to stimulate attendance. Hence we plan to
compare the effectiveness of two alternative approaches for school-based dental
screening in promoting dental attendance and reducing untreated dental caries
among primary school children.
The study will be conducted among school-going
children of Dharwad city who are aged between 7 and 12 years. From 10 schools selected, 100 children will dental
screened to meet a quota of at-least 70 children ( total of 700 in 10 schools).
stratified random selection will be done to select 140 children who will
receive improvised screening protocol. All the 700 children will be
visited after 3 months from the date of screening for confirming whether the
child completed the dental visit and also about the dental treatments
undertaken. Comparison of rate of dental attendance following improvised
screening protocol with traditional school based oral screening will be done.recruitment is planned to begin from 15th of July and
the follow up is expected to be completed by 15th January 2025 (subject to CTRI
registration prior to 15th July 2024 ) |